ART improves quality of life modestly

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Rather than treatment side-effects having a negative impact on people’s quality of life when they start HIV treatment, data from the large randomised START study show a modest but statistically significant improvement in quality of life, the recent Conference on Retroviruses and Opportunistic Infections (CROI 2016) in Boston heard.

While the ability of antiretroviral treatment to protect the immune system and prevent serious illnesses in the long term is generally accepted by people considering starting treatment, some individuals continue to be concerned that side-effects may harm their quality of life. Negative beliefs about antiretrovirals being “strong” or “toxic” medicines can contribute to some people preferring to delay HIV treatment until they feel it is ‘really necessary’.

For example, in one recent qualitative study a newly diagnosed Australian gay man talked about starting treatment: “Yeah, it’s a little bit scary. I don’t mind going on treatment. I’m just worried about it being toxic in my body over a long period of time and how I might cope with that. But if I need to go on – and I probably will – when I need to, then I’ll start treatment.”

The Strategic Timing of AntiRetroviral Treatment (START) study has already provided definitive evidence of the benefit of starting treatment promptly. The trial enrolled 4,685 men and women with HIV who had never taken ART, were in generally good health and had a CD4 cell count over 500 cells/mm3. Based on random allocation, half the participants started ART immediately, while the other half deferred treatment until their CD4 cell count declined to 350 cells/mm3. Those who deferred treatment knew that they had done so (they were not given a placebo).

Before the trial began, the researchers identified serious Aids-related illnesses, serious non-Aids illnesses and death as the outcomes by which the benefit of immediate treatment would be judged. In the group starting treatment immediately, 1.8% of participants experienced one of these events, compared with 4.1% in the deferred treatment group – a 57% reduction. The most common events in both arms were tuberculosis and cancers.

However these serious events are quite rare. In deciding whether to start treatment, some people may also be concerned about less serious health issues and drug side-effects which could affect larger numbers of people.

The researchers therefore also collected data on health-related quality of life, asking study participants to rate their own quality of life on a regular basis. Four measures were used. Participants made a self-assessment of their health, using both a “visual analogue scale” (marking a score somewhere between 0 to 100 for their current health) and rating their general health as either poor, fair, good, very good or excellent. They were asked about whether pain had recently interfered with their normal work. They were asked how often they had felt calm and peaceful in the past month.

Each time data were collected, the researchers compared the ratings with those given at baseline, at the beginning of the study.

After beginning treatment, people gave higher ratings for their current and general health, while those in the deferred arm gave similar or slightly lower ratings than they did before. Throughout follow-up, all four measures of quality of life were better rated by the immediate treatment group (p – less than – 0.001 for each measure). These differences were modest, but statistically significant.

For those beginning treatment earlier, there was a particular improvement in the frequency with which people said they had felt calm and peaceful.

The researchers note that the START study recruited people who were generally in good health and had not yet taken HIV treatment. Maintaining a good quality of life after starting HIV treatment is an important goal for this group, they say. “These findings provide further support to the superiority of early ART as reported for major clinical outcomes in the START study,” they conclude.

With HIV managed as a chronic illness, quality of life (QOL) is one important outcome in assessing HIV treatment strategies. Development of HIV-related illnesses or medication side effects can both affect QOL. The Strategic Timing of Antiretroviral Therapy (START) study randomized antiretroviral therapy (ART) naive participants with CD4 counts – more than – 500 cells/mm3 to starting ART immediately vs. deferring ART until CD4 counts declined to 350 cells or clinical disease required ART. We compared immediate vs. deferred ART groups for changes in QOL.
At baseline, Month 4, 12 and then annually, participants completed a visual analogue scale (VAS) for self-assessment of overall current health and the Short-Form 12-Item Health Survey version 2 (SF-12v2) with 4 week recall. We computed three QOL outcomes from SF-12v2: (1) General health perception (GHP); (2) Physical component summary (PCS), and (3) Mental component summary (MCS). All QOL outcomes are scaled 0-100 (higher score=better QOL). PCS and MCS scores are standardized to a mean=50 in a U.S. reference population. We compared immediate and deferred ART groups for QOL changes from baseline using longitudinal mixed models adjusted for visit and baseline QOL.
Of 4684 START participants, 4561 had both baseline and follow-up QOL data: median baseline CD4=651 cells, median age=36 years, 27% were female, and 46% from high-income countries. Mean QOL baseline scores (with standard deviation) were VAS=80.9 (15.7), GHP=72.5 (21.5), PCS=53.7 (7.2), MCS=48.2 (10.5). Mean follow-up time was 2.6 years. The immediate group spent 95% of follow-up time on ART vs. 28% for the deferred group. Throughout follow-up, all changes in QOL favored the immediate group; modest but significant differences were seen as early as 4 months with increases through 12 months (Fig. 1). Estimated treatment differences during follow-up were: VAS=1.9 (95% CI 1.2-2.5); GHP=3.6 (2.8-4.5); PCS=0.8 (0.5-1.1); MCS=0.9 (0.4-1.3) (p – less than –0.001 for each QOL measure).
In this HIV-positive population with CD4 – more than – 500 cells/mm3 that was generally in good health, all QOL measures improved in the immediate compared to the deferred ART group. These findings provide further support to the superiority of early ART as reported for major clinical outcomes in the START study.

Background: In recent years, there has been increasing evidence that early initiation of antiretroviral therapy (ART) may provide health benefits for those infected with HIV. There has also been significant discussion about the role of HIV treatment in preventing onward transmission of the virus. Early provision and uptake of ART to people recently diagnosed with HIV could achieve both individual and public health outcomes. The success of such an initiative relies, in part, on the preparedness of those recently diagnosed with HIV to engage with the therapy. Methods: The HIV Seroconversion Study collects both quantitative and qualitative data from people in Australia who have recently been diagnosed with HIV. During 2011–2012, 53 gay or bisexual men recruited across Australia took part in semistructured interviews as part of the study. The men were asked about their knowledge and experience of, and their decisions about whether or not to commence, HIV treatment. Results: The interviews identified differing levels of knowledge about HIV treatments and divergent views about the health and prevention benefits of ART. For some, treatments provided a sense of control over the virus; others were apprehensive and distrustful, and preferred to resist commencing treatments for as long as possible. Conclusions: If early initiation of treatment is to be encouraged, appropriate measures must be in place to ensure recently diagnosed individuals have access to the appropriate information and the support they need to enable them to make informed choices and, if necessary, to address their fears.

Aidsmap material
CROI 2016 abstract
Sexual Health abstract

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